Sr. Clinical Data Manager

Description

Position Summary:

We are seeking an experienced Senior Clinical Data Manager to lead and oversee data management activities for an IDE trial, with a focus in structural heart. You will be responsible for providing hands-on leadership of all data management aspects of the clinical trial from start to finish. Your primary focus will be ensuring data integrity, quality, and compliance with clinical trial requirements to ensure “submission-ready” data for FDA as well as other regulatory bodies.

The ideal candidate will have expertise in clinical data management, regulatory compliance, and database maintenance, with a strong understanding of clinical trial processes in the medical device industry. This role requires strong cardiovascular knowledge, prior experience with investigational medical device clinical trials, excellent project management skills, and the ability to collaborate effectively with cross-functional teams.

KEY RESPONSIBILITIES

Clinical Data Operations, Quality Control & Oversight

• Lead all aspects of data management for the medical device clinical trial, ensuring compliance with FDA, MDR, ICH-GCP, and ISO 14155 regulations.
• Develop and maintain Data Management Plans (DMPs) and Case Report Forms (CRFs) aligned with study protocols as well as development of training materials as applicable.
• Manage the  Electronic Data Capture (EDC) systems. 
• Oversee data cleaning, query management, and reconciliation processes to ensure high-quality, analyzable datasets.
• Ensure adherence to CDISC/CDASH/SDTM standards, enabling efficient regulatory submission.
• Conduct and support data audits, quality control (QC) reviews, and database lock activities.
• Implement and manage data trending assessment activities queries, etc.
• Perform routine validation checks and implement QC measures to guarantee "submission-ready" accuracy.
• Ensure data is compliant with project and data management plans for data handling and sharing with the clinical research team.
• Oversee and perform User Acceptance Testing (UAT)
• Support the clinical research team and sites in the daily use of data systems and ensure adherence to legal and company standards.
• Facilitate stakeholders are properly trained to utilized our data management system.
• Lead manual listing review activities according to the DMP.
• Manage ongoing query review with closures of system-generated queries according to the DMP.
• Lead the distribution of data reports, extracts, and other deliverables as defined in the data management plan.
• Conduct data management meetings as appropriate and provide the clinical team updates regarding data listings, issues, cleaning, and locking. 
• Lead and coordinate the creation of study-specific eCRF Completion Guidelines.
• Assures databases and archives are protected from security breaches and losses.
• Manage troubleshooting activities for data-related problems

Project and People Leadership

• Serve as the data management lead for the IDE trial, collaborating with cross-functional teams including clinical operations, biostatistics, and regulatory affairs.
• Work closely with structural heart experts, principal investigators, and clinical research teams to ensure accurate data collection and interpretation.
• Provide mentorship and guidance to junior data manager and other team members.
• Manage relationships with CROs, vendors, and external data management teams, ensuring alignment with project timelines and quality standards.

Regulatory Compliance & Quality Assurance

• Ensure compliance with FDA 21 CFR Part 11, ICH-GCP, ISO 14155 (for medical devices), and MDR regulations.
• Support regulatory submissions (e.g., PMA, CE Mark, IDE) by ensuring proper data documentation and formatting.
• Participate in audits and inspections by regulatory bodies and implement corrective actions as needed.
• Stay updated on evolving medical device data management best practices and regulatory requirements.
• Develop, maintain and execute procedures and plans for data handling.
• Be responsible for preparation of all data-related summaries required to support scientific and regulatory submissions.

Date Reporting & Analysis

• Generate and review clinical study reports, data listings, and reconciliation outputs.
• Support statistical programming and data analysis as needed.
• Serve as a Subject Matter Expert (SME) for all data management inquiries.

Requirements

 Education and Experience:

• Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related technical field.
• Certification in clinical data management (e.g. CCDM) preferred.
• 5 to 10 years of experience, with 3-5 years as senior/lead role, in clinical data management in investigational medical device industry. 
• Proven experience in IDE/PMA/510(k) submissions, or post-market studies.
• Experience managing EDC systems (e.g., Medidata RAVE, Catchtrials).
• Proven track record of managing the full data lifecycle in a small-to-midsize company environment where ownership of multiple priority projects is required.

Knowledge, Skills and Abilities:

• Advanced proficiency in EDC systems (e.g., Medidata Rave, CatchTrials), data management software and CRF design.
• Strong knowledge of structural heart trials is a plus but not required.
• Familiarity with ISO 14155, CDISC/CDASH/SDTM, and FDA 21 CFR Part 11 compliance.
• Knowledge of SQL, SAS, or other clinical data programming tools is beneficial.
• Familiarity with relevant regulations and guidelines such as GCP and CDISC standards.
• Understanding of data privacy and protection regulations (e.g., GDPR).
• Excellent attention to detail with problem-solving and analytical skills.
• Strong organizational and time management abilities with the ability to adapt quickly.
• Effective communication and interpersonal skills to collaborate with other teams